MT-601 Administered To Patients With Locally Advanced Unresectable or Metastatic Pancreatic Cancer

NCT ID: NCT06549751

Last Updated: 2024-08-12

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-30
• Study Completion Date: 2027-12-31

Brief Summary

The goal of this clinical trial is to assess safety and tolerability of escalating doses of MT-601 administered during the off week of chemotherapy regimen for patients with pancreatic cancer. The main question[s] it aims to answer are: safety and efficacy • overall response rate and duration of response. Participants will meet all applicable inclusion criteria prior to chemotherapy and must agree to provide apheresis material.

Detailed Description

The Dose Escalation portions will proceed using a standard 3+3 design. Flat doses of MT-601 will be administered ranging from 200 million cells to 400 million cells. For the Dose Expansion, MT-601 will be administered at the dose determined to be safe based on the results from the Dose Escalation portion. Front-line chemotherapy (FOLFIRINOX or gemcitabine/nab-paclitaxel) will be administered as per standard of care. MT-601 will be administered intravenously over 10 minutes (± 5 minutes) during the "off" week of front-line chemotherapy. Patients will receive up to 6 infusions of MT-601 approximately every 4 weeks.

Conditions

Pancreas Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Escalation

Cohort -1 / 100 million cells / 3-6 patients Cohort 1 / 200 million cells / 3-6 patients Cohort 1 / 400 million cells / 3-6 patients

Group Type: EXPERIMENTAL

MT-601

Intervention Type: BIOLOGICAL

Cellular Therapy

Expansion

The Dose Expansion portion will begin after completion of the Dose Escalation portion and focus on the efficacy of MT-601 as add-on to front-line chemotherapy. The dose level for the expansion portion of the study will be selected based on totality of the data. The primary objective is to evaluate clinical efficacy for the dose expansion. A total of 20 to 25 patients are planned to be enrolled.

Group Type: EXPERIMENTAL

MT-601

Intervention Type: BIOLOGICAL

Cellular Therapy

Interventions

MT-601

Cellular Therapy

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

1. Cytologically or histologically confirmed newly diagnosed locally advanced, unresectable or metastatic pancreatic adenocarcinoma (excluding other pancreatic malignancies such as acinar cell carcinomas or neuroendocrine cell neoplasms, etc.).

2. Eligible for reassessment following 2 months of front-line chemotherapy (FOLFIRINOX or gemcitabine/nab-paclitaxel): Patient must have experienced a response of SD, PR, or CR per RECIST v1.1 after 2 months of front-line chemotherapy (FOLFIRINOX or gemcitabine/nab-paclitaxel).

3. ≥18 years of age prior to administration of MT-601.

4. Measurable or evaluable disease per RECIST v1.1 at the time of screening.

5. Must have sufficient leukapheresis material to manufacture autologous MT601.

6. Performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) scale.

7. Life expectancy ≥12 weeks.

8. Pulse oximetry of >90% on room air in patients with previous radiation therapy.

9. Adequate organ function, as defined below:

• Absolute neutrophil count (ANC) ≥1.5 × 109/L
• Platelets ≥75 × 109/L
• Hemoglobin ≥9 g/dL (can be transfused)
• International normalized ratio (INR) or prothrombin time (PT) ≤1.5 × upper limit of normal (ULN) (unless patient receiving stable dose of anticoagulant therapy as long as PT or INR in therapeutic range of intended anticoagulant)
• Partial thromboplastin time (PTT) or activated partial thromboplastin time (aPTT) PTT or aPTT ≤ 5 seconds above ULN (unless patient receiving stable dose of anticoagulant therapy "a" as long as PT or INR in therapeutic range of intended anticoagulant)
• Total bilirubin ≤2 × ULN
• Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤3 × ULN OR ≤5 × ULN if liver has tumor involvement
• Serum creatinine OR calculated (as per institutional standards) creatinine clearance ≤2 × ULN OR measured or calculated ≥50 mL/min for patients "a" If receiving anticoagulation, the patient must have no active bleeding within 14 days prior to baseline assessment.

10. Sexually active patients must be willing to utilize one of the highly effective birth control methods or practice complete abstinence between initiation of screening for MT-601 infusion and 6 months after the last MT-601 infusion. Male patients who are sexually active must agree to use a condom during this period.

11. Disease imaging prior to administration of front-line chemotherapy and reimaging prior to administration of MT-601.

Exclusion Criteria

• N/A

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Marker Therapeutics, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Patricia Allison, BS

Role: STUDY_DIRECTOR

Marker Therapeutics

Central Contacts

Patricia Allison, BS

Role: CONTACT

pallison@markertherapeutics.com

7174715205

Other Identifiers

MRKR-22-601-02

Identifier Type: -

Identifier Source: org_study_id